Ultrasound-assisted varicose vein surgery and endovenous laser ablation using 1470-nm laser for treatment of great saphenous vein incompetence has similar outcomes at 1 year in a single-center prospective randomized study.

BACKGROUND: Technical errors are the most common preventable cause of recurrence after high ligation and stripping procedures for the treatment of great saphenous vein incompetence. Ultrasound-assisted varicose vein surgery (UAVS) uses intraoperative ultrasound during high ligation and stripping to minimize such failures, although no data have been reported regarding its use during open surgery. The present study compared the short-term outcomes of UAVS and endovenous laser ablation (EVLA) with a 1470-nm laser. METHODS: The present prospective randomized study was conducted from January 2019 to December 2019. We compared 40 patients who had undergone UAVS under regional anesthesia with an equal number of patients who had undergone EVLA under tumescent anesthesia. Both groups received 1 week of standardized postoperative analgesia. The improvements in the pain score, venous clinical severity score, and recurrence at 6 months and 1 year were studied. RESULTS: No significant differences were found in either clinical or radiologic great saphenous vein recurrence after UAVS compared with EVLA at 1 year. The mean pain score at 8 hours after the procedure was higher in the UAVS group (3.7 ± 1.2 vs 2.9 ± 1.0; P = .03). At 1 week, the score was higher in the EVLA group (1.8 ± 0.7 vs 1.4 ± 0.5; P = .01). At 6 months, the venous clinical severity score had improved from 9.2 ± 3.7 to 2.4 ± 1.4 in the UAVS group and from 9.3 ± 3.2 to 2.1 ± 0.8 in the EVLA group (P = .64). At 1 year, the corresponding scores were 1.3 ± 0.7 and 1.4 ± 0.6 (P = .21). CONCLUSIONS: UAVS has high technical success, making it a suitable alternative to EVLA using a 1470-nm laser.

A multicenter randomized controlled trial of cyanoacrylate closure and surgical stripping for incompetent great saphenous veins.

OBJECTIVE: The treatment of varicose veins has shifted from conventional surgical stripping (SS) to minimally invasive endovenous modalities. Cyanoacrylate closure (CAC) with the VenaSeal system (Medtronic, Dublin, Ireland) has increased in popularity owing to its nonthermal and nontumescent technique. The purpose of the present study was to compare the clinical outcomes of CAC and SS for the treatment of incompetent great saphenous veins. METHODS: An open-label, multicenter, prospective, randomized controlled trial was conducted. The subjects were randomized to either the CAC or SS procedure. The primary endpoint of the present study was to evaluate complete closure of the target vein at 3 months. Target vein occlusion was assessed on the third day and 1, 3, 6, and 12 months postoperatively using duplex ultrasound. The pain and ecchymosis grades were also assessed. Additionally, the clinical outcomes, such as the venous clinical severity score and Aberdeen Varicose Vein Questionnaire score, were assessed. RESULTS: Three-month follow-up data were obtained for all 126 enrolled and randomized subjects (63 with CAC and 63 with SS). At 3 months, complete target vein closure was observed in both groups. The postoperative pain score was significantly better in the CAC group than in the SS group (0.3 ± 0.6 in the CAC group and 1.1 ± 1.5 in the SS group; P < .001). In addition, the mean ecchymosis grade was 0.3 ± 0.5 in the CAC group and 1.1 ± 1.1 in the SS group (P < .001). The venous clinical severity score and quality of life had improved equally in both groups. The adverse events after both procedures were mostly minor complications (9 events in CAC group and 20 events in SS group). Major complications occurred in one patient who had undergone the SS procedure. CONCLUSIONS: The CAC and SS procedures were both associated with complete occlusion of the target vein at 3 months. The postoperative pain and ecchymosis grades were significantly lower in the CAC group. Other differences between the two groups included the frequency and nature of the complications. The results showed that CAC has high success with few complications.

Endovenous microfoam ablation of below knee superficial truncal veins is safe and effective in patients with prior saphenous treatment across a wide range of CEAP classes.

OBJECTIVE: Patients requiring thermal or chemical ablation of below knee (BK) truncal veins often have their proximal saphenous veins treated initially and comprise a study population with multilevel, refractory chronic venous insufficiency. The study objective was to assess the outcomes after microfoam ablation of BK truncal and tributary veins in patients with a history of proximal great saphenous vein (GSV) ablation or stripping. METHODS: A retrospective review of a prospectively maintained database was performed. All the patients who had undergone endovenous chemical ablation with commercially manufactured polidocanol microfoam for symptomatic BK truncal vein reflux after a previous saphenous ablation or stripping were identified. The patients had undergone duplex ultrasound scanning 48 to 72 hours after the procedure; those who had not adhered to the recommended follow-up protocol were excluded. The demographic data, CEAP (clinical, etiologic, anatomic, pathophysiologic) classification, venous clinical severity score (VCSS), procedure details, adverse thrombotic events, and follow-up data were abstracted. RESULTS: Between April 2018 and April 2021, 201 limbs were treated for symptomatic superficial truncal vein reflux with microfoam ablation. Of the 201 limbs, 68 in 49 patients met the inclusion criteria for the present study. The veins treated included the BK GSV (n = 45) and small saphenous vein (n = 23). The median follow-up was 97 days (range, 33-457 days) for the entire cohort. Most patients (63%) had a preoperative CEAP classification of C4 to C6. The median preoperative VCSS was 12.5. All the limbs that had undergone microfoam ablation in this cohort had a previously treated proximal ipsilateral GSV, with either thermal ablation or stripping. The median postoperative VCSS after BK treatment decreased to 10 (P < .001). The closure rate at the last follow-up was 96%. The overall symptomatic relief was 78% at the last follow-up. The absolute ulcer healing rate during the study period was 64% (16 of 25 ulcers had healed). One patient had developed thrombus extension into the popliteal vein, which resolved with anticoagulation therapy. One asymptomatic patient had developed nonocclusive thrombus in a gastrocnemius vein after small saphenous vein ablation. Because she was asymptomatic, anticoagulation therapy was not prescribed. Postoperative pain, phlebitis, and swelling were reported in 12%, 12%, and 2% of patients, respectively, and all had resolved at the last follow-up visit. Three limbs treated with chronic oral anticoagulant agents had had recanalized truncal veins during the study period after initial closure. No pulmonary emboli or neurologic adverse events were reported. No symptoms of saphenous or sural nerve injury had occurred. CONCLUSIONS: Endovenous chemical ablation with commercially manufactured polidocanol microfoam of BK truncal veins is a safe and effective treatment for patients with severe, refractory chronic venous insufficiency and prior saphenous interventions. This technique results in excellent overall closure rates and symptomatic relief with low adverse venous thrombotic events, across a wide range of CEAP classes.

The presence of a pathologic perforator may be predictive of central venous pathology and multilevel disease in severe chronic venous insufficiency.

OBJECTIVES: The treatment of a refluxing perforator is indicated in the setting of severe chronic venous insufficiency, but there are limited data on the presence of multilevel disease in these patients. This study sought to evaluate whether the presence of a pathologic perforator is predictive of the presence of central venous pathology. METHODS: This study was a retrospective review of the institutional Vascular Quality Initiative database. Consecutive patient limbs were identified that underwent intervention of refluxing perforators. The patients who underwent imaging, including magnetic resonance imaging or computed tomography (group A), were compared with those who did not undergo imaging (group B). The treated limbs in group A were also compared with the contralateral limbs as an internal control. Anatomical findings on imaging were analyzed by two independent investigators. The primary outcome was the presence and degree of central venous stenosis as measured by an orthogonal diameter reduction of >50% by axial imaging. Secondary outcomes included demographic and clinical differences between the two groups, frequency of central venous intervention, and duration of ulcer healing. Standard statistical analysis was performed. RESULTS: Ninety-three patient limbs underwent treatment of a pathologic perforator, with 30 in group A and 63 in group B. The following demographic and clinical variables were higher in group A compared with group B: male sex, body mass index, deep venous thrombosis history, recent or active anticoagulation use, perforator diameter, Clinical Etiology Anatomy Pathophysiology class 4, 5, or 6, and Venous Clinical Severity Score. Radiographic analysis of group A revealed concordance of a treated pathologic perforator with an ipsilateral central venous stenosis in 53.3% of patients, and a higher frequency of common iliac vein stenosis (50% vs 21.4%, P = .024) and external iliac vein stenosis (20% vs 0%, P = .012) compared with the contralateral limbs. When separated by the left or right limb, the left limbs exhibited a greater degree of common iliac vein stenosis as compared with the contralateral limbs (50.7% ± 20.9% vs 16.3% ± 16.5%, P < .001) as well as a greater frequency of >50% common iliac vein stenosis (46.7% vs 13.3%, P = .046). The right limbs exhibited a greater frequency of >50% external iliac vein stenosis as compared with the contralateral limbs (33.3% vs 0%, P = .022). CONCLUSIONS: This study suggests that patients with severe chronic venous insufficiency who undergo treatment for a pathologic perforator may have additional ipsilateral central venous pathology, supporting the presence of multilevel disease. Additional axial imaging might unmask central venous pathology and provide another option for treatment.

Radiofrequency Ablation for Axial Reflux Associated with Foam Sclerotherapy for Varicosities in One-Step Approach: A Prospective Cohort Study Comprising Large Diameters Saphenous Veins.

OBJECTIVE: This study assessed the outcomes and impact on the quality of life following one-step outpatient radiofrequency ablation (RFA) and ultrasound guided foam sclerotherapy (USGFS) for large reflux with varicosities in the great saphenous vein (GSV). DESIGN: Prospective, single-centre, analytical cohort. MATERIALS AND METHODS: Thirty symptomatic patients having reflux in the GSV and varicosities (CEAP C3 to C6) were treated with RFA and USGFS simultaneously, in a single-step procedure, from March 2016 to December 2016. They were followed up at 1 week, 6 months, 1 and 3 years. Clinical outcomes, changes in the Quality of Life (QOL) questionnaires SF-36™, VCSS and AVVQ, evolutive vein occlusion rates were assessed by duplex ultrasound, and ulcer closure was checked. RESULTS: The sample was divided into two groups: (Group 1) GSV diameter ≥13.0 mm (median 19.0 [14-24]), 17 subjects, and (Group 2) GSV diameter ≤12.9 mm (median 10.3 [10-12]), 16 subjects. No major adverse event was observed, and the postoperative minor adverse event rates were similar between the two groups. A significant improvement was observed in VCSS and AVVQ from the preoperative levels to the sixth month and the third-year follow-up. Twelve of 13 ulcers had healed at 1 year and remained closed until 3 years. The entire sample had a significant increase in all short form 36 domains, except for mental health in the Group 2 (GSV ≥ 13.0 mm). Overall first week occlusion rate for the whole sample was 90.9% and 69.7% at the 3-year follow-up. No difference in occlusion rate was observed between the two groups at any time. CONCLUSION: Exclusively outpatient combined techniques were safe and feasible in this study with no major adverse events, despite the large diameters of the GSV or ulcer presence. Within 3 years, both diameter groups showed equivalent improvement in all QOL parameters, satisfactory axial occlusion, and maintained ulcer closure.

Imaging of Pelvic Venous Disorders (PeVD); Should Every Patient Get an MRI?

Pelvic venous disease (PeVD) is part of the broad differential diagnosis of chronic pelvic pain with a challenging diagnosis and clinical workup to identify those patients that are most likely to benefit from intervention. Ultrasound, MRI, CT, venography, and intravascular ultrasound can all provide information to aid in the diagnostic algorithm. The purpose of this article is to review imaging as a component of the outpatient workup of patients with chronic pelvic pain to guide appropriate understanding and use of imaging modalities to accurately identify patients suffering from PeVD. A favored approach is to begin with transabdominal sonography with selective use of MRI/MRV in specific patient populations.

Clinical Presentation and Evaluation of Pelvic Venous Disorders in Women.

The term pelvic venous disorders (PeVD) describes a group of related clinical entities with overlapping clinical presentations that were previously characterized by separate imprecise syndromic terminology. The clinical manifestations of PeVD may variously include chronic pelvic pain; pelvic origin extrapelvic lower extremity and genital varices; lower extremity pain and swelling; and left flank pain and hematuria. This manuscript focuses on the primary manifestations of PeVD in women - chronic pelvic pain and pelvic origin lower extremity and vulvar varices - and will review the underlying pathophysiology and related complicating factors (such as maladaptive pain responses) to explain the variety of clinical presentations.

Ovarian Vein Embolization: How and When Should It Be Done?

Pelvic Venous Disease (PeVD) is characterized by pelvic varicosities and chronic pelvic pain, defined as noncyclic pelvic pain that persists for more than 6 months. Pain and discomfort related to PeVD typically worsen with upright positioning and occur more frequently in multiparous and premenopausal women. The most common cause of PeVD is pelvic venous insufficiency (PVI) due to incompetent valves. Noninvasive imaging modalities such as ultrasound, computed tomography, or magnetic resonance imaging, and invasive catheter-based venography can help characterize varicosities and venous insufficiency, supporting the diagnosis of PeVD. In patients with PeVD, ovarian and/or internal iliac vein embolization demonstrate excellent technical and clinical success rates with relatively low complication rates and should be considered as standard management, in conjunction with medical therapy. Appropriate diagnostic work-up and patient selection are important prior to any intervention for achieving therapeutic success, as multiparous women have a higher success rate compared to patients with dyspareunia after embolization therapy. Post-procedure follow-up is critical for assessing symptom improvement and need for repeat intervention. However, further research is needed to identify additional predictors of successful outcomes after embolization therapy. This article aims to provide an overview of patient selection, interventional technique, challenges, and outcomes of ovarian vein embolization.

Patients with chronic venous insufficiency in the times of COVID-19 and the risk of thrombus formation - suggestions on conservative treatment of such patients based on the principles of pathophysiology.

The current limitations of surgical treatment, as well as restrictions on professional and sport activities related to COVID-19 pandemic require seeking therapeutic solutions for the vast population of patients with chronic venous insufficiency (CVI, chronic venous insufficiency). To understand the principles of pharmacotherapy of this disease, the authors used data related to epidemiology and pathophysiology of CVI. They provided the latest data on venoactive drugs and recommendations that should be followed and summarized the literature based on the EBM. The article should provide the answer to the question of how to deal with patients with varicose veins or, more broadly, chronic venous insufficiency during the pandemic.

Efficiency of Prophylactic Ablation of the Tributary Venous Pathways Draining Around the Saphenofemoral Junction to Decrease the Rate of Future Varicose Vein and Symptoms Occurence.

BACKGROUND: There are various other collaterals draining into the venous system around the saphenofemoral junction in addition to the great saphenous vein. We aimed to determine the efficiency of prophylactic ablation of tributary veins in long term varicose vein and symptom recurrence. METHODS: Two hundred and sixty-three consecutive patients whom underwent radiofrequency ablation therapy for the treatment of superficial venous reflux disease were investigated. There were 129 patients who received isolated great saphenous vein ablation (Group A) where as 134 patients underwent ablation of the other tributary veins in addition to the great saphenous vein (Group B) between June 2015 and January 2017. The tributary superficial veins; refluxing and/or not refluxing, draining into the saphenofemoral junction were selectively catheterized and ablated in Group B. Patients are followed at least 1 year after the procedures regulary and researched for recurrence of varciose veins and symptoms. RESULTS: Gender, mean age, body mass index, diameter of the great saphenous veins, small saphenous vein disease, and grade of deep venous insufficiency did not differ significantly between the two groups. The mean number of tributary veins were similar in both groups (n: 1.9 ± 0.4 in Group A vs. n: 1.8 ± 0.7 in Group B) which were detected preoperatively as well as during the procedure. The mean number of ablated tributary venous pathways could be 1.4 ± 0.6 in Group B. During the follow up period symptoms related with varicose veins recurred in 19 patients in Group A where as in 7 patients in Group B (P < 0.05). Three of these symptomatic patients in Group B were the ones in whom the tributary pathways could not be catheterized ablated where as 14 patients in Group A were diagnosed with newly refluxing tributary pathways. All the symptomatic patients in both groups were managed medically and/or with additional interventions. CONCLUSION: The absence of any fascial unsheathing and the parietal weakness are suggestive of a lower resistance of the tributary veins wall, so collapse and size of veins make it more complex to catheterization regarding to great saphenous vein. Ablation of the tributary superficial venous pathways during the treatment of great saphenous vein reflux disease decreased the rate of recurrence of superficial venous reflux disease and patients symtoms in our modest cohort.

The Symptoms-Varices-Pathophysiology classification of pelvic venous disorders: A report of the American Vein & Lymphatic Society International Working Group on Pelvic Venous Disorders.

As the importance of pelvic venous disorders (PeVD) has been increasingly recognized, progress in the field has been limited by the lack of a valid and reliable classification instrument. Misleading historical nomenclature, such as the May-Thurner, pelvic congestion, and nutcracker syndromes, often fails to recognize the interrelationship of many pelvic symptoms and their underlying pathophysiology. Based on a perceived need, the American Vein and Lymphatic Society convened an international, multidisciplinary panel charged with the development of a discriminative classification instrument for PeVD. This instrument, the Symptoms-Varices-Pathophysiology ("SVP") classification for PeVD, includes three domains-Symptoms (S), Varices (V), and Pathophysiology (P), with the pathophysiology domain encompassing the Anatomic (A), Hemodynamic (H), and Etiologic (E) features of the patient's disease. An individual patient's classification is designated as SVPA,H,E. For patients with pelvic origin lower extremity signs or symptoms, the SVP instrument is complementary to and should be used in conjunction with the Clinical-Etiologic-Anatomic-Physiologic (CEAP) classification. The SVP instrument accurately defines the diverse patient populations with PeVD, an important step in improving clinical decision making, developing disease-specific outcome measures and identifying homogenous patient populations for clinical trials.

[Anatomy of foot perforator veins in surgery of varicose veins]. / Anatomiya perforantnykh ven stopy v khirurgii varikoznoi bolezni.

OBJECTIVE: To clarify the role of clinical anatomy of foot and ankle perforator veins (PV) in surgical treatment of varicose vein disease. MATERIAL AND METHODS: Anatomy of foot and ankle PV was assessed in 50 amputated lower extremities by anatomical dissection. RESULTS: There were 4-6 PVs at the medial surface of the foot. These veins connected medial marginal vein and vv. plantaris medialis (VPM). There were 2-3 PVs at the lateral surface of the foot. These veins connected lateral marginal vein and vv. plantaris lateralis (VPL). All PVs on the lateral surface of the foot constitute the neurovascular bundles. PVs flowing into vv. dorsalis pedis are localized on the medial surface of the medial marginal vein at the level of the ankle base. In most cases, we found an arterial branch nearby at the subfascial level. In anterior part of the plantar surface of the foot, we distinguished 4-5 small PVs (~1 mm) flowing into vv. digitales plantares through the commissural orifices of the aponeurosis. There were 6-9 vessels (~1 mm) along the fascial aponeurotic septa. These vessels connected superficial plantar venous network and plantar veins. Small arterial branch was found almost in all cases near these veins. Noteworthy is the area where the plantar veins lie on the quadratus plantae and are covered by a leaf of deep plantar fascia. This anatomy is similar to topography of posterior tibial veins. CONCLUSION: Foot perforator veins constitute the neurovascular bundles as a rule. Plantar vein topography and their relationship with PV confirm an existence of muscular-venous pump of the foot.

Inferior selective crossectomy for great saphenous vein incompetence: Our experience.

OBJECTIVE: To describe the mid-term outcome after inferior selective crossectomy in a subset of patients with symptomatic chronic venous disease and both great saphenous vein and suprasaphenic valve incompetence.Methodsː Retrospective analysis of prospectively collected data was conducted. During an eight-year period, 1095 ligations of all saphenofemoral junction inferior tributaries and great saphenous vein stripping were performed in 814 Clinical, Etiology, Anatomy, Pathophysiology C2-C6 patients. Duplex ultrasound follow-up examinations were performed after 30 days, 6 months, and 2 years, and saphenofemoral junction hemodynamic patterns and varicose veins recurrence rates were evaluated. RESULTS: Two hundred and twenty patients completed the two-year follow-up period. At the 30-day Duplex ultrasound evaluations, two different hemodynamic patterns were described. Type 1, with physiological drainage of saphenofemoral junction superior tributaries, was observed in 214 patients. Type 2, without flow in saphenofemoral junction superior tributaries, was observed in six patients. Overall varicose vein recurrence rates were 0, 2.3, and 2.7% at the 30-day, 6-month, and 2-year follow-up examinations, respectively. At the two-year follow-up, Type 1 patients showed 0% varicose vein recurrence, while Type 2 patients showed 100%.Conclusionsː Inferior selective crossectomy seems to be a valid and safe option in case of both suprasaphenic valve and great saphenous vein incompetence. Duplex ultrasound evaluation, according to our protocol, allows us to identify two different saphenofemoral junction hemodynamic patterns that could predict varicose vein recurrence at mid-term. An optimal stump washing after inferior selective crossectomy, warranted by patency and large caliber saphenofemoral junction superior tributaries, seems to be the key point in preventing varicose vein recurrence in this context. However, large prospective studies regarding saphenofemoral junction modifications and varicose vein recurrence are needed to confirm these preliminary observations.

Iliocaval outflow obstruction in patients with venous ulcers in a small comparison study between patients with primary varicose veins and chronic deep vein disease.

OBJECTIVE: Iliocaval outflow obstruction was investigated in patients with venous ulcers caused by primary superficial disease and chronic deep vein disease METHODS: After clinical assessment, patients with healed or active venous leg ulcers underwent lower extremity duplex ultrasound examination to identify the presence of venous disease in the superficial, deep and perforating systems. Bilateral contrast venography and intravascular ultrasound examination were then performed to determine the presence and degree of iliocaval obstructive lesions. RESULTS: This retrospective study included a total of 59 patients with 71 legs presenting active or healed ulcer. There were 16 limbs (22.5%) with superficial venous reflux associated with normal infrainguinal deep veins (group I) and 55 limbs (77.5%) with infrainguinal post-thrombotic deep venous disease (group II). Using venography and intravascular ultrasound examination, the incidence of >50% of venous obstruction in the iliocaval system in groups I and II were 75% and 83.6%, respectively. All obstructive lesions in group I were nonthrombotic. However, group II included thrombotic, nonthrombotic and combinations of the two types of obstructions. Group II had more ulcers (1.73 ± 1.3 vs 1.17 ± 0.5; P = .03), larger ulcers (>6 cm in 34.1% vs 8.3%), longer duration of ulcers (71.3 ± 110.5 months vs 37.9 ± 40.4 months; P = .03), smaller diameter of refluxing superficial veins (7.7 ± 2.6 mm vs 15.1 ± 6.6 mm; P = .001), and higher incidence of occluded iliocaval systems (18 [32.7%] vs 0; P = .003) than group I. After the exclusion of bilateral cases and thrombotic obstructions, the incidence of >50% nonthrombotic obstruction in ipsilateral and contralateral sides was 76.5% and 24.4%, respectively (P = .003). CONCLUSIONS: The results of this study revealed that the majority of patients with venous ulcers with either infrainguinal primary superficial or post-thrombotic deep venous disease had an element of iliocaval venous obstruction.

Clinical outcomes of radiofrequency ablation for patients with varicose veins of the lower extremities combined with grade II iliac vein compression.

BACKGROUND: Iliac vein compression (IVC) is a common condition in patients with varicose veins (VVs) of the legs. IVC has been classified into three grades in previous studies. Grade II IVC is defined by >50% stenosis without the development of collateral circulation. The purpose of the present study was to investigate the outcomes of radiofrequency ablation (RFA) for patients with VVs combined with grade II IVC. METHODS: A retrospective analysis was conducted of 339 patients who had undergone RFA for VVs of the left leg from March 2017 to January 2019. Duplex ultrasonography, computed tomography venography, and venography were performed to evaluate for grade II IVC. All the patients were divided into two groups. Group 1 included patients with VVs only, and group 2, patients with VVs combined with grade II IVC. Propensity score matching was used to ensure an even distribution of confounding factors between groups. The venous clinical severity score (VCSS) and chronic venous insufficiency questionnaire (CIVIQ) score were recorded during the 12-month follow-up. Occlusion of the truncal veins was evaluated using duplex ultrasound scans. RESULTS: Using 1:1 propensity score matching, 50 pairs of patients were enrolled in the present analysis. The average age of groups 1 and 2 was 58.7 ± 13.1 and 60.1 ± 7.1 years, respectively. The VCSS had decreased significantly from baseline to 12 months postoperatively (group 1, from 5 to 1; group 2, from 4 to 1; P < .01). A significant increase in the CIVIQ score was found between the baseline and 12-month evaluations for both groups (group 1, from 62.5 to 69; group 2, from 63 to 70; P < .01). The truncal occlusion rate was 98% in both groups at 12 months. No significant differences were found between the two groups in the VCSS, CIVIQ score, procedure complications, or occlusion rate during the 12-month follow-up. CONCLUSIONS: RFA is effective for patients with VVs combined with grade II IVC.

A randomized controlled noninferiority trial comparing radiofrequency with stripping and conservative hemodynamic cure for venous insufficiency technique for insufficiency of the great saphenous vein.

OBJECTIVE: The quality of available evidence regarding new minimally invasive techniques to abolish great saphenous vein reflux is moderate. The present study assessed whether radiofrequency ablation (RFA) was noninferior to high ligation and stripping (HLS) and conservative hemodynamic cure for venous insufficiency (CHIVA) for clinical and ultrasound recurrence at 2 years in patients with primary varicose veins (VVs) due to great saphenous vein (GSV) insufficiency. METHODS: We performed a randomized, single-center, open-label, controlled, noninferiority trial to compare RFA and 2 surgical techniques for the treatment of primary VVs due to GSV insufficiency. The noninferiority margin was set at 15% for absolute differences. Patients aged >18 years with primary VVs and GSV incompetence, with or without clinical symptoms, C2 to C6 CEAP (Clinical, Etiologic, Anatomic, Pathophysiologic) clinical class, and GSV diameter >4 mm were randomized with a 1:1:1 ratio to RFA, HLS, or CHIVA. The rate of clinical recurrence at 24 months was the primary endpoint and was analyzed using a delta noninferiority margin of 15%. Ultrasound recurrence, safety, and quality of life were secondary endpoints. RESULTS: From December 2012 to June 2015, 225 limbs had been randomized to RFA, HLS, or CHIVA (n = 74, n = 75, and n = 76). Clinical follow-up and Doppler ultrasound examinations were performed at 1 week and 1, 6, 12, and 24 months postoperatively. No differences in postoperative complications or pain were observed among the three groups. RFA was noninferior to HLS and CHIVA for clinical recurrence at 24 months, with an estimated difference in recurrence of 3% (95% confidence interval [CI], -4.8% to 10.7%; noninferiority P = .002) and -7% (95% CI, -17% to 3%; P < .001), respectively. For ultrasound recurrence, RFA was noninferior to CHIVA, with an estimated difference of -34% (95% CI, -47% to -20%; noninferiority P < .001) at 24 months. However, noninferiority could not be demonstrated compared with HLS (5.9%; 95% CI, -4.1 to 15.9; P = .073). No differences were found in quality of life among the three groups. CONCLUSIONS: RFA was shown to be noninferior in terms of clinical recurrence to HLS and CHIVA in the treatment of VVs due to GSV insufficiency.

Effect of endovenous ablation assessment stratified by great saphenous vein size, gender, clinical severity, and patient-reported outcomes.

OBJECTIVE: The policies of insurance carriers have used the truncal vein size as a criterion for coverage. The objective of the present study was to compare the effect of great saphenous vein (GSV) size ≥5 mm vs <5 mm on patient presentation and clinical outcomes. METHODS: Patients in a national cohort were prospectively captured in the Vascular Quality Initiative Varicose Vein Registry. From January 2015 to October 2017, the Vascular Quality Initiative Varicose Vein Registry database was queried for all patients who had undergone varicose vein procedures. The CEAP (clinical, etiologic, anatomic, pathophysiologic) classification, Venous Clinical Severity Score, and patient-reported outcomes were compared by GSV size (<5 mm, group 1; ≥5 mm, group 2) before and after the procedures. A 2-sample Wilcoxon test was performed to assess the differences between the 2 groups stratified by GSV size. To assess for postoperative improvement, a matched-pairs Wilcoxon signed rank test was performed for each group separately. RESULTS: During the study period, 5757 vein ablation procedures had been performed for GSV: 770 for GSV size <5 mm and 4987 for GSV size ≥5 mm. Patients in group 1 were more likely to be women (81.7% vs 68.4%; P = .001) and older (56.8 vs 55.6 years; P = .012). The CEAP clinical class was more advanced in group 2 than in group 1 (P = .001). The maximal GSV diameter in group 2 was significantly greater than in group 1 (8.32 vs 3.86 mm; P = .001); 64% of group 2 and 59.2% of group 1 had undergone radiofrequency thermal ablation (P = .001). No mortalities occurred in either group. Group 2 had more complications postoperatively (0.6% vs 0%; P = .027), required postoperative anticoagulation (8.8% vs 5%, P = .001), developed partial recanalization (0.8% vs 0.3%; P = .001), and missed more work days (2.32 vs 1.6 days) compared with group 1. A similar rate of hematoma developed in both groups, but group 1 had a higher rate of paresthesia. Both groups had improvement in the Venous Clinical Severity Score and HASTI (heaviness, achiness, swelling, throbbing, itching) score. The degree of symptomatic improvement between the 2 groups was similar. CONCLUSIONS: All patients demonstrated improvement in both clinical outcomes and patient-reported outcomes after endovenous ablation, regardless of GSV size. Patients with a preoperative GSV size ≥5 mm experienced similar improvement in symptoms but an increased complication rate. Patients with a smaller vein size should not be denied intervention or coverage by vein size.

Results of polidocanol endovenous microfoam in clinical practice.

BACKGROUND: Initial phase III clinical studies with polidocanol endovenous microfoam (PEM) demonstrated its safety and efficacy in the treatment of superficial venous reflux. In those studies, the primary outcome requirement was to assess the improvement in symptoms related to superficial venous disease. The goal of the present study was to evaluate the efficacy of PEM technology in routine clinical practice-specifically, the closure rates after treatment. METHODS: We performed an observational study during which data were prospectively collected from 2 vein centers using an electronic database. Patients with CEAP (clinical, etiologic, anatomic, pathophysiologic) class ≥2 and symptomatic superficial axial reflux (great saphenous vein, anterior accessory saphenous vein, and small saphenous vein) were included and followed up prospectively. PEM was used to treat the saphenous vein and varicosities. The CEAP classification was used to classify chronic venous disease, and the venous clinical severity score (VCSS) was applied to measure the disease severity. Pain and discomfort were assessed using a visual analog scale, and the residual veins were assessed by physical examination. RESULTS: PEM was used to treat superficial reflux in 60 patients. The CEAP classification was C2 for 32 patients, C3 for 14, C4 for 10, and C5 for 4 patients. The average pretreatment VCSS was 7.3. The saphenous vein diameter was 6.5 mm, and the average length was 31 cm. The average volume of PEM used to treat the saphenous veins was 9.3 mL. The closure rate at 3 and 6 months was 93% (54 of 58) and 93% (51 of 55), respectively. The VCSS had improved from 7.3 to 1.4. Complications included 1 case of deep vein thrombosis (1.7%), 5 patients (8.3%) with thrombophlebitis, and 4 patients (6.6%) with skin pigmentation. CONCLUSIONS: PEM is safe and effective for the treatment of saphenous reflux and varicosities. The early closure rates using PEM were maintained at 6 months and are comparable to the results reported with nonthermal, nontumescent technologies and thermal tumescent technologies.

Recurrence types 3 years after endovenous thermal ablation in insufficient saphenofemoral junctions.

OBJECTIVE: Although many studies have demonstrated that endovenous therapies have comparable efficacy to crossectomy and stripping, few studies have been published regarding the classification and recurrence patterns of varicose veins after endovenous therapy. This study attempted to provide an objective scheme for the definition and classification of recurrence. Moreover, it describes the types and rates of recurrence after endovenous thermal ablation, as well as factors associated with recurrence. METHODS: This prospective cohort study comprised a cohort of 449 patients with saphenofemoral junction (SFJ) insufficiency who underwent endoluminal varicose vein treatment for the first time in the limb between October 2013 and January 2015. The treatments were performed by a team of three experienced phlebologists. For endovenous laser ablation, Biolitec ELVeS was used with bare, radial or radial slim fibers. Radiofrequency ablation was performed with VNUS ClosureFAST (Medtronic, Deggendorf, Germany). The patients were consecutively scheduled for 3-year follow-up examinations. Detailed ultrasound findings were collected by two experienced phlebologists who classified the observed duplex ultrasound recurrence into different recurrence types. RESULTS: Clinically relevant recurrence was found in only 5.1% of cases. Examining only the recanalizations requiring reintervention resulted in a recurrence rate of 2.6%. However, if every new varicose vein that occurred postoperatively was considered a recurrence, the resultant recurrence rate was almost 54%. Preliminarily, we defined a recurrence as newly developed varicose veins within the region of the SFJ or along the course of the former treated vein distal to the SFJ. According to this definition, we obtained a clinically relevant recurrence rate of 5.3%, thus indicating that neovascular vessels were the largest recurrence type (57.7% within the region of the SFJ and 9.9% distal to the SFJ), followed by recanalization (8.9% within the region of the SFJ and 9.4% distal to the SFJ) and a refluxing anterior accessory saphenous vein (7.5%). We also developed a modified classification of progression to better understand recurrence after treatment of chronic venous insufficiency; the scheme included method failure (recanalization), neovascularizations, and disease progression (refluxing untreated vessels and new varicose veins occurring outside the treated region). The diameter of the treated vein (P = .001) and the clinical class according to CEAP classification (P = .008) were significant predictors of recurrence. CONCLUSIONS: Endoluminal therapies are efficient methods for the treatment of varicose veins, which result in low recurrence rates after 3 years. Several factors influence the development of recurrence. This study provides a practice-oriented classification and description of recurrence with clinical relevance, through making distinctions among technical error, progression of the underlying disease and actual recurrence.